Trends in Use and Expenditures of Brand-name Atorvastatin After Introduction of Generic Atorvastatin

Rising brand-name pharmaceutical expenditures can be significantly mitigated with generic substitution, particularly for high-volume categories, such as statins.^1,2 Pfizer’s Lipitor (atorvastatin calcium) was the best-selling drug of all time until a generic version became available in the United States in November 2011.³ However, national use of Lipitor and the financial impact of generic availability are unknown. Therefore, we analyzed trends in use and expenditures associated with Lipitor after generic atorvastatin availability.

We analyzed US adults 18 years or older in the nationally representative, longitudinal Medical Expenditure Panel Survey (MEPS) database from 2012 to 2014. Details about MEPS design and cost and use ascertainment have been previously published.⁴ Survey participants self-reported medication names, number of prescriptions, out-of-pocket (OOP) cost, and payment source; pharmacies provided total expenditure and utilization. The Multum Lexicon database, code 173, was used to identify statins, classified as brand-name or generic, based on trade name reported. After adjusting to 2014 US dollars using a gross domestic product deflator, we estimated national and per-user expenditure, and OOP costs associated with Lipitor and generic atorvastatin. Excess expenditure associated with Lipitor use was determined, similar to prior publications,¹ as the difference between the actual and projected expenditures if all Lipitor users substituted it with generic atorvastatin. Because the MEPS consists of publicly available, deidentified data files, this current study was deemed exempt from Baptist Health South Florida institutional review board approval, per the US Department of Health and Human Services guidelines.

From 2012 to 2014, of 110 789 MEPS participants, 75 174 were eligible for the study (age, mean [standard error], 47.0 [0.2] years; 52% were female). From 2012 to 2014, overall atorvastatin users increased 20%, from 12.5 million adults (5.3% of US adults) to 15.0 million adults (6.2% of US adults), and prescriptions increased from 50.3 million to 74.0 million (Table). Lipitor use decreased from 3.9 million adults in 2012 to 0.7 million adults in 2014, with a concomitant increase in uptake of generic statin from 8.6 million in 2012 to 14.3 million in 2014.

In this time period, total atorvastatin-associated expenditures decreased from $7.0 billion to $5.4 billion. Total national expenditures associated with Lipitor were $3.5 billion (50% of total atorvastatin cost) in 2012 vs $357 million (7% of total cost) in 2014. Excess expenditure associated with continued Lipitor use totaled $2.1 billion from 2012 to 2014 (Figure). More than half (57%) of excessive spending ($1.2 billion) was noted among patients with Medicare or Medicaid, who accounted for 58% of Lipitor users. We found that per-user total expenditure for Lipitor were higher compared with generic throughout 2012 to 2014. However, in 2014, Lipitor per-user OOP cost was lower than generic atorvastatin ($27 vs $49).

Availability of generic atorvastatin led to a 28% reduction in atorvastatin-associated expenditures from 2012 to 2014, despite a 20% increase in overall atorvastatin use in the United States. However, persistent prescription of Lipitor resulted in $2.1 billion in excess expenditure from 2012 to 2014.

A report in a privately insured cohort showed that Lipitor prescription resulted in high OOP costs in the 6 months of generic exclusivity given limited competition.³ Our study adds to this report by providing national estimates of expenditures associated with Lipitor from both private and publically financed insurance programs, showing more than $110 million in excess expenditures on Lipitor beyond the first year of generic introduction. Furthermore, we found that Lipitor OOP cost was lower than that of generic in 2014, likely owing to deals made with pharmacy benefit managers to lower Lipitor copays below that of generics.⁵ These findings support developing measures promoting generic prescription, which are essential to addressing health care expenditures. Swifter generic substitution is essential to reduce wasteful spending and promoting value in the US health care system.

Corresponding Author: Khurram Nasir, MD, MPH, MSc, Section of Cardiovascular Medicine, Yale School of Medicine, Center for Outcomes Research and Evaluation, Yale University & Yale New Haven Health System, 1 Church St, Suite 200 New Haven, CT 06510 (khurram.nasir@yale.edu).

Accepted for Publication: February 12, 2018.

Published Online: March 10, 2018. doi:10.1001/jamainternmed.2018.0990

Author Contributions: Dr Nasir had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Study concept and design: Warraich, Salami, Khera, Okunrintemi, Nasir.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Warraich, Salami, Okunrintemi, Nasir.

Critical revision of the manuscript for important intellectual content: All authors.

Statistical analysis: Salami, Khera, Valero-Elizondo, Okunrintemi.

Administrative, technical, or material support: Nasir.

Study supervision: Warraich, Salami, Nasir.

Conflict of Interest Disclosures: Dr Nasir serves on the advisory board of Quest Diagnostics. No other disclosures are reported.

Additional Information: Drs Warraich and Salami contributed equally to this study.

Meeting Presentation: This study was presented at the American College of Cardiology 2018 Scientific Sessions; March 10, 2018; Orlando, Florida.